An exciting contract opportunity has arisen for an experienced QC Analyst currently working within the Pharmaceutical / Biopharmaceutical industry to join the team in a leading biopharmaceutical company in South Dublin. Experience with general test methods such as Ph, Appearance, Colour, Clarity, Sub Visible Particle testing, Osmolality, Protein Concentration, Polysorbate, Moisture and Device testing is required. Technical writing experience such as being involved in updating SOPs is desired. This is not an entry level position so at least 2 years' industry experience within a GMP laboratory is needed.
Responsibilities will include:
* Plan and perform analyses with great efficiency and accuracy.
* Plan and perform multiple, complex routine/ non-routine methods and procedures and a large variety of assays.
* Report, evaluate, back-up/archive, trend and approve analytical data.
* Troubleshoot, solve problems and communicate with stakeholders.
* Initiate and/or implement changes in controlled documents.
* Participate in audits, initiatives and projects that may be departmental or organizational in scope.
* Review protocols and perform assay validation and equipment qualification/ verifications when required.
* Introduce new techniques to the lab, including method transfers, reports, validations and protocols
* May contribute to regulatory filings.
* May conduct lab investigations as necessary.
* LIMS data coordination of commercial and import testing on site where applicable
* May represent the department/organization on various teams. May train others.
Relevant experience:
* Bachelor's degree in a Science related field is required.
* 3+ years of biopharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical or medical device industry,
* Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products.
The successful candidate will:
* Be very proficient in the use of Microsoft Word, Excel etc.
* Have strong communication and technical writing skills.
* Investigation skills
* Be detail oriented, self-motivated with good troubleshooting and problem-solving abilities.
* Be a self-starter and capable of working on own initiative.
* Strong teamwork skills.
* Proven track record of meeting deadlines.
* Experience with analytical techniques such as Compendial testing would also be advantageous